Description:

The goal of the trial was to evaluate treatment with AMG 145, a monoclonal antibody, against proprotein convertase subtilisin/kexin type 9 (PCSK9) compared with placebo among stable patients with hypercholesterolemia treated with a statin.

Principal Findings:

Overall, 631 patients were randomized. The mean age was 62 years, 51% were women, mean body mass index was 29 kg/m2, 16% had diabetes, 30% had coronary artery disease, and 99% were taking a statin medication.

Serious adverse events were low and ranged from 0 to 5%. There were no treatment-related adverse events that led to study drug discontinuation.

Interpretation:

Among stable patients with hypercholesterolemia, PCSK9 inhibition by AMG 145 reduced LDL-C, non-HDL-C, and apolipoprotein-B in a dose-dependent fashion without serious adverse events. Further study in phase 3 trials is warranted.